A federal court has ruled that Medicare Part D does not cover off-label use of prescription drugs for cancer treatment. The decision came in the case of Marlene Cavagnuolo, who sought coverage for her late husband's cancer treatment. This ruling affects many Medicare beneficiaries who rely on off-label prescriptions for their health care.
The case, Cavagnuolo v. Becerra, was filed in the District Court for the District of Columbia under Civil Action No. 2023-3369. The court's decision centers on the interpretation of the term "covered part D drug" as defined in the Medicare statute. The outcome is significant as it clarifies the requirements for drug coverage under Medicare Part D, particularly regarding off-label uses.
Marlene Cavagnuolo filed the lawsuit after her husband, Joseph Cavagnuolo, was denied coverage for the drug Olaparib, which was prescribed for his Stage-IV lung cancer. The drug is FDA-approved for other types of cancer but not for lung cancer, making its use considered "off-label." The denial of coverage was based on the interpretation of Medicare regulations that require drugs to be used for a "medically accepted indication" to qualify for coverage.
The dispute began when Joseph Cavagnuolo's health plan, Mutual of Omaha Rx, denied the request for preapproval of Olaparib. The plan stated that the drug's use was not approved by the FDA for lung cancer and was not listed in any clinical resources for evaluating Part D coverage. After several appeals, including a review by an administrative law judge (ALJ), the denial was upheld. Following Joseph's death, his wife continued to pursue the case on behalf of his estate.
The court's ruling was issued by Magistrate Judge Matthew J. Sharbaugh, who recommended that the court deny Mrs. Cavagnuolo's motion for summary judgment and grant the Secretary of Health and Human Services' cross-motion for summary judgment. The judge concluded that the Secretary's interpretation of the Medicare statute was correct. The court stated, "The Secretary’s interpretation wins out," emphasizing that the term "includes" in the statute is definitional and not illustrative.
The ruling clarifies that for a drug to be covered under Medicare Part D, it must be used for a medically accepted indication, which is defined in the statute. This means that drugs prescribed for off-label uses may not be covered, even if they are FDA-approved for other conditions.
This decision has significant implications for Medicare beneficiaries who may rely on off-label prescriptions for their treatment. It reinforces the need for drugs to meet specific criteria to qualify for coverage under Medicare Part D. The ruling aligns with previous court decisions that have similarly interpreted the Medicare statute regarding drug coverage.
Moving forward, this ruling may impact how Medicare beneficiaries approach their treatment options, particularly when considering off-label drug use. It also raises questions about the accessibility of certain treatments for patients with complex medical needs.
The case may be appealed, but details regarding any potential appeal were not available in the court filing. This ruling sets a precedent for how Medicare interprets drug coverage and may influence future cases involving off-label drug use.